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Summary  Pegfilgrastim is a pegylated form of the granulocyte‐colony stimulating factor, filgrastim. Herein, we report the results of a multicentre, randomized, double‐blind phase  III  trial comparing the efficacy and safety of pegfilgrastim with filgrastim in patients with malignant lymphoma. Patients were randomized to receive either a single subcutaneous dose of pegfilgrastim or daily subcutaneous doses of filgrastim on day 4 after the completion of cyclophosphamide, cytarabine, etoposide and dexamethasone ± rituximab ( CHASE (R); day 1–3) chemotherapy. The primary endpoint was the duration of severe neutropenia ( DSN ), defined as the number of days with neutrophil count <0·5 × 10 9 /l in the first cycle of chemotherapy. A total of 111 lymphoma patients were randomized to either the pegfilgrastim or filgrastim group. 109 patients received either pegfilgrastim ( n  = 54) or filgrastim ( n  = 55). Efficacy data were available for 107 patients (pegfilgrastim:  n  = 53, filgrastim:  n  = 54). Both groups were well balanced in terms of gender, age, performance status and other variables. The mean  DSN  (±S.D.) was 4·5 (±1·2) and 4·7 (±1·3) d in the pegfilgrastim and filgrastim groups. No significant difference in safety was observed. This trial verified the non‐inferiority of a single subcutaneous dose of pegfilgrastim compared with daily subcutaneous doses of filgrastim, considering  DSN  as an indicator.

british journal of haematology

A randomized, double‐blind trial of pegfilgrastim versus filgrastim for the management of neutropenia during  CHASE (R) chemotherapy for malignant lymphoma